ETSense: Adaptive Portable Essential Tremor Monitor

描述（由申请人提供）：目的是设计、实施和临床评估ETSense，一种自适应、紧凑、便携式特发性震颤（ET）监测仪，用于优化治疗干预。在美国，40岁以上的人群中约有4%患有ET，其主要特征是肢体的体位性和动动力（动作）震颤，这些震颤由各种主观震颤评定量表（TRS）评定。这些量表都在一个离散的时间点提供了一个离散的、主观的症状评级，需要临床医生直观地评估患者，并且不能捕捉到全天因干预而发生的复杂波动。在日常活动中持续客观地捕捉ET症状，并使用自适应算法对震颤类型和严重程度进行分类，将有助于临床医生更好地滴定治疗，以最大限度地减少症状波动，并将护理扩大到农村和服务不足的人群。CleveMed此前开发了一种名为“ParkinSense”的紧凑型无线系统，用于量化帕金森病（PD）的症状。在临床研究中，该系统成功地实现了PD运动症状的客观量化。PD的研究结果表明，通过开发特定的ET算法和更连续的便携式监测来捕捉全天可能发生的震颤波动，该系统可能适用于量化ET患者的震颤。提出的系统的主要创新将是紧凑、便携的用户穿戴硬件，用于在日常生活活动中进行连续监测，以及智能、自适应算法，以连续分类震颤类型和频率严重程度。包括加速度计和陀螺仪的组合将提供一个系统，比目前现有的单轴系统具有更高的震颤类型识别和严重程度等级灵敏度。最终的系统将包含在一个轻量级的，手指佩戴的外壳中，不需要PC，可以在家里或公共场合连续佩戴。该设备将检测到运动（震颤或自主），开始数据收集。设备上的一个按钮将允许患者指示何时服药。所有数据将存储在存储器中，以供后续分析和报告生成，详细说明对治疗干预的反应的症状波动。ETSense将为持续评估ET症状提供标准化平台。这种便携式设计将允许患者在家中、工作场所或公共场合执行日常任务，同时存储震颤类型和严重程度。临床报告将详细描述症状波动，以优化治疗干预措施和制定新的治疗方案。公共卫生相关性：特发性震颤，主要表现为运动时的震颤，影响了美国大约4%的40岁以上人口。在临床检查中，存在各种主观评定震颤严重程度的震颤评定量表。提出的ETSense自适应便携式原发性震颤监测仪将在患者进行典型活动时连续一整天对震颤类型和震颤严重程度进行分类，这将有助于临床医生更好地处方治疗并帮助开发新的治疗干预措施。

DESCRIPTION (provided by applicant): The objective is to design, implement, and clinically assess ETSense", an adaptive, compact, portable essential tremor (ET) monitor for optimizing therapeutic interventions. ET affects approximately 4% of the population over age 40 in the United States and is characterized primarily by postural and kinetic (action) tremors of the limbs, which are rated by various subjective tremor rating scales (TRS). These scales all provide a discrete, subjective symptom rating at a discrete point in time, require a clinician to visually assess the patient, and cannot capture complex fluctuations that occur throughout the day in response to interventions. Objectively capturing ET symptoms continuously during daily activities and using adaptive algorithms to both classify tremor types and severity will help clinicians better titrate therapy to minimize symptom fluctuations and expand care to rural and underserved populations. CleveMed has previously developed a compact wireless system to quantify Parkinson's disease (PD) symptoms called ParkinSense". In a clinical study, this system successfully demonstrated objective quantification of PD motor symptoms. The promising results for PD suggest the system may be adapted for quantifying tremor in ET patients by developing specific ET algorithms and more continuous portable monitoring to capture the tremor fluctuations that can occur throughout the day. The primary innovation of the proposed system will be compact, portable user worn hardware for continuous monitoring during activities of daily living and intelligent, adaptive algorithms to continuously classify tremor type and rate severity. Including a combination of accelerometers and gyroscopes will provide a system with much greater sensitivity for tremor type discrimination and severity rating than currently existing uniaxial systems. The final system will be contained in a lightweight, finger-worn housing that does not require a PC and can be worn continuously at home or in public. The device will detect motion (tremor or voluntary) to begin data collection. A button on the device will allow the patient to indicate when medication is taken. All data will be stored in memory for subsequent analysis and report generation detailing symptom fluctuations in response to therapeutic interventions. ETSense will provide a standardized platform for continuous evaluation of ET symptoms. The portable design will allow patients to perform everyday tasks at home, at work, or in public while tremor type and severity is stored. Clinical reports will detail symptom fluctuations for optimizing therapeutic interventions and the development of novel treatment protocols. PUBLIC HEALTH RELEVANCE: Essential tremor, characterized primarily by tremor during movement, affects approximately 4% of the population over age 40 in the United States. Various tremor rating scales exist for subjectively rating tremor severity during a clinical exam. The proposed ETSense adaptive, portable essential tremor monitor will classify tremor type and rate tremor severity continuously throughout the day while a patient performs typical activities, which should help clinicians to better prescribe treatment and aid in the development of novel therapeutic interventions.